510(k) K211856
K211856 is an FDA 510(k) premarket notification submitted by Electrocore, Inc. for the device "gammaCore Sapphire". The FDA issued a decision of Substantially Equivalent on September 10, 2021. The device falls under product code PKR (Non-Invasive Vagus Nerve Stimulator - Headache), a Class II device regulated under 21 CFR 882.5892. Electrocore, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 10, 2021
- Date Received
- June 16, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Non-Invasive Vagus Nerve Stimulator - Headache
- Device Class
- Class II
- Regulation Number
- 882.5892
- Review Panel
- NE
- Submission Type
The device intended for non-invasive vagus nerve stimulation (nVNS) on the side of the neck to treat cluster headache and to reduce the frequency of cluster headache attacks.